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NCT00000871 · ClinicalTrials.gov registry record · Phase 2
A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
NCT00000871 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 420 participants.
The verdict
NCT00000871, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
Study Summary
To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. \[AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.\] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. \[AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.\]
Interventions
- BIOLOGICAL rgp120/HIV-1 SF-2
- BIOLOGICAL MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- BIOLOGICAL MN rgp120/HIV-1 and A244 rgp120/HIV-1
- BIOLOGICAL ALVAC-HIV MN120TMG (vCP205)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Est. Completion | 2000-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000871
The ClinicalTrials.gov registry entry for NCT00000871 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which rgp120/HIV-1 SF-2 is the first listed.
NCT00000871 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000871 about?
NCT00000871 is a clinical study titled "A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers". To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. \[AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to pr...
What is the current status of trial NCT00000871?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 420 participants. Estimated completion is 2000-01.
What interventions are being tested in trial NCT00000871?
The interventions under investigation include: rgp120/HIV-1 SF-2 (BIOLOGICAL), MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 (BIOLOGICAL), MN rgp120/HIV-1 and A244 rgp120/HIV-1 (BIOLOGICAL), ALVAC-HIV MN120TMG (vCP205) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000871?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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